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Clinical Trial Details

Trial ID: L6864
Source ID: NCT01881828
Associated Drug: Metformin (Glucophage)
Title: Metformin Therapy for Overweight Adolescents With Type 1 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01881828/results
Conditions: Type 1 Diabetes
Interventions: DRUG: Metformin (glucophage)|OTHER: oral placebo
Outcome Measures: Primary: Change in Hemoglobin A1c From Baseline to 26 Weeks, Adjusted for Baseline Hemoglobin A1c., Hemoglobin A1c is a measure of glycemic control over approximately the past 3 months, 0-26 weeks | Secondary: Change in Total Daily Dose of Insulin (TDI) Per kg, 0-26 weeks|Change in Body Mass Index (BMI), 0-26 weeks|Change in Waist Circumference, 0-26 weeks|Change in Body Composition, Change in percent body fat, 0-26 weeks|Change in Serum Lipids, 0-26 weeks|Change in Blood Pressure, 0-26 weeks | Other: Change in Liver Enzymes and Serum Creatinine, 0-26 weeks|Frequency of Severe Hypoglycemia, 26 weeks|Frequency of Diabetic Ketoacidosis, 26 weeks|Frequency of Gastrointestinal Side-effects Including Stomach Discomfort, Diarrhea, Nausea/Vomiting, Indigestion, Flatulence., 26 weeks|Frequency of Lactic Acidosis, 26 weeks|Change in Adipocytokines, 0-26 weeks|Change in Androgen Levels in Females, 0-26 weeks|Change in C-peptide, Measured with mixed meal tolerance test among participants with evidence of residual C-peptide on a non-fasting C-peptide at screening, 0-26-weeks|Change in Vascular Dysfunction, 0-26 weeks
Sponsor/Collaborators: Sponsor: Jaeb Center for Health Research | Collaborators: Juvenile Diabetes Research Foundation
Gender: ALL
Age: CHILD, ADULT
Phases: PHASE3
Enrollment: 164
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2013-09
Completion Date: 2014-12
Results First Posted: 2018-12-19
Last Update Posted: 2020-03-03
Locations: Jaeb Center for Health Research, Tampa, Florida, 33647, United States
URL: https://clinicaltrials.gov/show/NCT01881828